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Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer

Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04165993
Collaborator
(none)
68
Enrollment
1
Location
3
Arms
72
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Concurrent chemotherapy and KN026
  • Drug: KN026 monotherapy
  • Drug: KN026 combination
 Phase 2

Detailed Description

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
Actual Study Start Date :
Dec 31, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Concurrent chemotherapy and KN026

KN026 combined with docetaxol

Drug: Concurrent chemotherapy and KN026
30 mg/kg Q3W KN026 75 mg/m2 docetaxol
Other Names:
  • docetaxol

    		•
    Experimental: KN026 monotherapy

    KN026 monotherapy

    Drug: KN026 monotherapy
    30 mg/kg Q3W KN026
    Other Names:
  • KN026

    		•
    Experimental: A combination treatment of KN026 and KN046

    KN026 combined with KN046

    Drug: KN026 combination
    30 mg/kg Q3W KN026 5 mg/kg Q3W KN046
    Other Names:
  • KN046

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [Throughout the duration of the study; up to 2 years]

      Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment

    2. Duration of response (DOR) [up to 2 years]

      Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment

    Secondary Outcome Measures

    1. Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest [Throughout the duration of the study]

      AEs, SAEs

    2. Progression free survival (PFS) rates [6 months and 12 months]

      Progression free survival (PFS) rates

    3. Overall survival (OS) rates [6 months and 12 months]

      Overall survival (OS) rates

    4. durable benefit rate (DBR) [DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks]

      durable benefit rate (DBR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female subject >= 18 years

    • Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer

    • ECOG score 0 or 1

    • Life expectancy >3 months

    • According to the definition of RECIST1.1, the patient has at least one measurable lesion

    • Adequate organ function prior to start treatment with KN026

    • Able to understand, voluntarily participate and willing to sign the ICF

    Exclusion Criteria:

    • Accepted any other anti-tumor drug therapies within 4 weeks before fist dose

    • Accepted radiotherapy within 4 weeks before enrollment

    • Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible

    • Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study

    • History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation

    • History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation

    • Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Harbin Medical University Cancer Hospital Harbin Heilongjiang China

    Sponsors and Collaborators

    • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    Investigators

    • Principal Investigator: Qingyuan Zhang, Professor, Harbin Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT04165993
    Other Study ID Numbers:
    • KN026-201
    First Posted:
    Nov 18, 2019
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Docetaxel

    Study Results

    No Results Posted as of Nov 17, 2021